Growth Hormone Replacement Therapy for Retried Professional Football Players

Part of paid clinical trials in Dearborn, Michigan.

Sponsor
Center for Neurological Studies
Study ID
NCT04121780
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Anterior Pituitary Hyposecretion Syndrome
  • Concussion, Brain
  • Growth Hormone Deficiency
  • Hypopituitarism
  • Sport Injury
  • TBI (Traumatic Brain Injury)

Eligibility Criteria

Sex
MALE
Age
18 Years - 76 Years
Healthy Volunteers
Not accepted

Interventions

  • Growth Hormone — BIOLOGICAL
    Daily self-injections by subjects: 1-year double-blind phase; 6-month open-label extension for those who received placebo during the double-blind phase
  • Placebo — OTHER
    Daily self-injections by subjects: 1-year double-blind phase

Study Details

This is a randomized, double-blind, placebo-controlled, parallel-group trial with an open-label extension to evaluate the efficacy of growth hormone (GH) on cognitive functions of retired professional football players with growth hormone deficiency (GHD).

Key Dates

Start date
Oct 8, 2019
Status verified
Feb 2023
Primary completion
Mar 31, 2025
Completion
Sep 30, 2026

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Growth Hormone
    Norditropin® (somatropin \[rDNA origin\] injection) via FlexPro® 30 mg / 3ml strength auto-injector pens (Novo Nordisk Inc).
  • Placebo Comparator: Saline
    Saline-placebo via auto-injector pens (Haselmeier Inc).

Primary Outcome Measure

Cognitive functions- Working Memory [ Time Frame: From baseline to 1-year post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Neurolgoical Studies (CNS)DearbornMichigan48126
Vijay Baragi, Ph.D.
[email protected]
313-228-0930
John Russell
[email protected]
3132280930

Find similar trials in Dearborn, MI

By research site
Center for Neurolgoical Studies (CNS)· Dearborn, MI

Related Studies